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Effect of Fufang Biejiaruangan Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis: A Multicenter, Randomized, Placebo-controlled Study
Sponsor: Nanfang Hospital, Southern Medical University
Summary
This study aims to establish a prospective, multicenter, randomized, double-blind, placebo-controlled parallel-group clinical trial cohort. The cohort will include high-risk populations for hepatitis B cirrhosis-related hepatocellular carcinoma (HCC) from multiple centers nationwide, who meet the criteria of traditional Chinese medicine syndrome differentiation as Qi-zhi-xue\_yu syndrome and have an aMAP score \>60 points. The objective is to evaluate whether combining Bie-jia-ruan-gan with standard anti-hepatitis B virus therapy can further reduce the incidence of HCC in this high-risk population.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
1034
Start Date
2026-04-01
Completion Date
2028-11-30
Last Updated
2026-03-18
Healthy Volunteers
No
Interventions
Biejia-Ruangan compound
receive Biejia-Ruangan compound (2.0 g per dose, three times daily) in addition to standard antiviral therapy
Biejia-Ruangan compound simulant
receive Biejia-ruangan compound simulant (2.0 g per dose, three times daily) in addition to standard antiviral therapy